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NCT01849003 · ClinicalTrials.gov registry record · Phase 1
Study of the Effect of GS-6615 in Subjects With LQT-3
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01849003 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 24 participants.
The verdict
NCT01849003, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval in participants with Long QT-3 syndrome. This study will be performed in six cohorts of participants in a sequential manner, four single-dose cohorts followed by two multiple-dose cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be 1 day and 7 days, respectively. Participants will be confined at the study center from check-in until completion of assessments at discharge. Participants will be continuously monitored using real-time telemetry throughout the in-clinic confinement. Physical examinations including vital signs, laboratory analysis, electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed at defined time points throughout the study period. Assessment of adverse events and concomitant medications will continue throughout the duration of the study.
Interventions
- DRUG GS-6615
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01849003
The ClinicalTrials.gov registry entry for NCT01849003 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GS-6615 is the first listed.
NCT01849003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01849003 about?
NCT01849003 is a clinical study titled "Study of the Effect of GS-6615 in Subjects With LQT-3". This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval in participants with Long QT-3 syndrome. This study will be performed in six cohorts of participants in a sequential manner, four single-dose cohorts followed by two multiple-dose cohorts. Duration of treatm...
What is the current status of trial NCT01849003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01849003?
The interventions under investigation include: GS-6615 (DRUG).
Who is sponsoring clinical trial NCT01849003?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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